Biopharmaceuticals

Medicines made using living cells or biological molecules, such as recombinant proteins, monoclonal antibodies, nucleic acid medicines, vaccines and viral vectors. Because the product depends on the process, manufacturing changes need comparability data, and viral safety, process-related impurities and potency testing are central. PMDA counts biological and biotechnological products among the high-risk products whose manufacturing sites it inspects, including sites overseas. This is the general Japanese term; legal texts use narrower categories with their own definitions.